Label: WINNING HANDS ALCOHOL FREE- benzalkonium chloride soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 19, 2016

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  • Winning Hands Alcohol Free

    ​Active Ingredient

    Benzalkonium Chloride 0.13%

  • Winning Hands Alcohol Free

    Uses

    • Use in a variety of public facilities.
    • Use this product when soap and water are not available.
  • Winning Hands Alcohol Free

    Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
  • Winning Hands Alcohol Free

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense product onto dry hands. Rub hands together until hands are dry.
    • Use as needed between hand washes to reduce bacteria on the skin.
  • Winning Hands Alcohol Free

    Inactive Ingredients

    Deionized ​Water, Sodium PCA, PEG/PPG-8/3 Laurate, Dimethicone, DMDM Hydantoin, PEG-3 Cocamide, Fragrance, Iodoproynyl Btylcarbamate, D&C Green #5.

  • Winning Hands Alcohol Free

    Questions or Comments?Phone: (800) 777-9343

    MDS information:​(800) 891-4965

  • Winning Hands Alcohol Free

    Purpose

    Antiseptic

  • Winning Hands Alcohol Free

    KEEP OUT OF REACH OF CHILDREN

  • Winning Hands Alcohol Free

    Winning Hands Alcohol Free

    Nondrying-Nonflammable Alcohol Free Foaming Hand Sanitizer

    Net Contents: 1 gallon (U.S./E.U.) 3.78 L

    75204.jpg

  • INGREDIENTS AND APPEARANCE
    WINNING HANDS ALCOHOL FREE 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-752
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-752-043780 mL in 1 JUG; Type 0: Not a Combination Product11/12/201201/01/2016
    2NDC:65601-752-541000 mL in 1 BAG; Type 0: Not a Combination Product11/12/201201/01/2016
    3NDC:65601-752-55207900 mL in 1 DRUM; Type 0: Not a Combination Product11/12/201201/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/12/2012
    Labeler - Betco Corporation, Ltd. (070307547)
    Registrant - Betco corporation, Ltd. (070307547)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.070307547manufacture(65601-752)
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